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NCT03834753 · ClinicalTrials.gov registry record · Phase 3
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
A Phase 3 study of Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, sponsored by Outlook Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
- 20
- Study locations
NCT03834753: Completed Phase 3 study of Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, sponsored by Outlook Therapeutics.
NCT03834753 is a Phase 3 study of Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration that has completed, run by Outlook Therapeutics. The registered enrollment target is 228 participants, below the 1,505-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03834753, a Phase 3 study of Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, has completed, sponsored by Outlook Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
- 20
- Study locations
Study Summary
This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.
Primary Outcome
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
Conditions Studied
Interventions
- BIOLOGICAL bevacizumab
- BIOLOGICAL ranibizumab
Study Locations (20)
California
- Clinical Site - Arcadia
- Clinical Site - Beverly Hills
- Clinical Site - Campbell
- Clinical Site - Glendale
- Clinical Site - Laguna Hills
- Clinical Site - Long Beach
- Clinical Site - Mountain View
- Clinical Site - Oxnard
- Clinical Site - Palm Desert
- Clinical Site - Poway
- Clinical Site - Sacramento
- Clinical Site - Santa Maria
- Clinical Site - Tustin
Florida
- Clinical Site - Clearwater
- Clinical Site - Pinellas Park
- Clinical Site - Sarasota
- Clinical Site - Winter Haven
Arizona
- Clinical Site - Tucson
Colorado
- Clinical Site - Golden
Connecticut
- Clinical Site - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2021-07-08 |
| Phase | Phase 3 |
What the finished NCT03834753 record still lists
NCT03834753 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 1,505-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (85% lower).
The record links to 3 conditions, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which bevacizumab is the first listed.
NCT03834753 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03834753 about?
NCT03834753 is a clinical study titled "A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)". This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.
What is the current status of trial NCT03834753?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2019-06-25. Estimated completion is 2021-07-08.
What conditions does trial NCT03834753 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration.
What interventions are being tested in trial NCT03834753?
The interventions under investigation include: bevacizumab (BIOLOGICAL), ranibizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03834753?
This trial is sponsored by Outlook Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03834753 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Age-related Macular Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03834753's enrollment target sits among peer trials
228 14th of 74 higher than 61 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
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A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
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